DESCRIPTION OF BUSINESS	9 Months Ended
Sep. 30, 2022
DESCRIPTION OF BUSINESS
DESCRIPTION OF BUSINESS	1. DESCRIPTION OF BUSINESS CASI Pharmaceuticals, Inc. (“CASI” or the “Company”) (Nasdaq: CASI) is a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the United States, and throughout the world. The Company was incorporated in 1991, and in 2012, with new leadership, the Company shifted its business strategy to China and has since built an infrastructure in China that includes sales and marketing, medical affairs, regulatory and clinical development and in the foreseeable future, manufacturing. In 2014, the Company changed its name to “CASI Pharmaceuticals, Inc.” The majority of the Company’s operations and activities are now located and conducted in China. The Company is focused on acquiring, developing and commercializing products that augment its hematology/oncology therapeutic focus as well as other areas of unmet medical need. The Company is executing its plan to become a biopharmaceutical leader by launching medicines in the greater China market, leveraging its China-based regulatory, clinical and commercial competencies and its global drug development expertise. The Company launched its first commercial product, EVOMELA^® (Melphalan for Injection) in China in August 2019. In China, EVOMELA^® is approved for use as a conditioning treatment prior to stem cell transplantation and as a palliative treatment for patients with multiple myeloma. The other core hematology/oncology assets in the Company’s pipeline include CNCT 19, an autologous CD19 CAR-T investigative product (“CNCT19”); BI-1206, an antibody which has a novel mode-of-action, blocking the inhibitory antibody checkpoint receptor FcγRIIB to unlock anti-cancer immunity and enhance the efficacy of antibody-based immunotherapy in both hematological malignancies and solid tumors; CB-5339, a novel VCP/p97 inhibitor focused on valosin-containing protein (VCP)/p97 as a novel target in protein homeostasis, DNA damage response and other cellular stress pathways for therapeutic use in the treatment of patients with various malignancies; and CID-103, a full human IgG1 anti-CD38 monoclonal antibody recognizing a unique epitope that has demonstrated encouraging preclinical efficacy and safety profile compared to other anti-CD38 monoclonal antibodies. Liquidity and Capital Resources Since its inception in 1991, the Company has incurred significant losses from operations and, as of September 30, 2022, had incurred an accumulated deficit of $624.9 million. The Company believes that it has sufficient resources to fund its operations at least one year beyond the date that the interim consolidated financial statements are issued. As of September 30, 2022, the Company had a balance of cash and cash equivalents and restricted cash of $29.2 million, of which $22.2 million was held in the financial institutions in the PRC. The Company intends to continue to exercise tight controls over operating expenditures and will continue to pursue opportunities, as required, to raise additional capital and will also actively pursue non- or less-dilutive capital raising arrangements or opportunities. Risks and Uncertainties Since the second quarter of 2022, due to the outbreak of Omicron and other variants of COVID-19, the lockdown in Shanghai and restrictions in other major cities in China led to limitation of access to local hospitals, which had an adverse impact on the sales of EVOMELA® for the second and the third quarters. The restrictions also adversely impacted the enrollment of patients for the CNCT19 Phase II registration studies. Recently, the pandemic gradually spread nationwide in China, and many small and medium-sized cities have been upgrading their control measures ever since the third quarter. These series of control measures are expected to adversely impact our sales activities for the remainder of 2022. Given that such COVID-19 related restrictions are beyond our control, at this stage, it is unable to assess for how long such COVID-19 related restrictions may continue in China, and the full extent to which such restrictions may directly and indirectly impact our business operations. Considering the uncertainty of the development of COVID-19 pandemic, we will continue to pay close attention on the development of the COVID-19 pandemic and dedicate resources to take any necessary measures in a timely manner to minimize the unfavorable impact on our businesses and operations.

DESCRIPTION OF BUSINESS

9 Months Ended

Sep. 30, 2022

1. DESCRIPTION OF BUSINESS

CASI Pharmaceuticals, Inc. (“CASI” or the “Company”) (Nasdaq: CASI) is a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the United States, and throughout the world. The Company was incorporated in 1991, and in 2012, with new leadership, the Company shifted its business strategy to China and has since built an infrastructure in China that includes sales and marketing, medical affairs, regulatory and clinical development and in the foreseeable future, manufacturing. In 2014, the Company changed its name to “CASI Pharmaceuticals, Inc.” The majority of the Company’s operations and activities are now located and conducted in China. The Company is focused on acquiring, developing and commercializing products that augment its hematology/oncology therapeutic focus as well as other areas of unmet medical need. The Company is executing its plan to become a biopharmaceutical leader by launching medicines in the greater China market, leveraging its China-based regulatory, clinical and commercial competencies and its global drug development expertise.

The Company launched its first commercial product, EVOMELA^® (Melphalan for Injection) in China in August 2019. In China, EVOMELA^® is approved for use as a conditioning treatment prior to stem cell transplantation and as a palliative treatment for patients with multiple myeloma. The other core hematology/oncology assets in the Company’s pipeline include CNCT 19, an autologous CD19 CAR-T investigative product (“CNCT19”); BI-1206, an antibody which has a novel mode-of-action, blocking the inhibitory antibody checkpoint receptor FcγRIIB to unlock anti-cancer immunity and enhance the efficacy of antibody-based immunotherapy in both hematological malignancies and solid tumors; CB-5339, a novel VCP/p97 inhibitor focused on valosin-containing protein (VCP)/p97 as a novel target in protein homeostasis, DNA damage response and other cellular stress pathways for therapeutic use in the treatment of patients with various malignancies; and CID-103, a full human IgG1 anti-CD38 monoclonal antibody recognizing a unique epitope that has demonstrated encouraging preclinical efficacy and safety profile compared to other anti-CD38 monoclonal antibodies.

Liquidity and Capital Resources

Since its inception in 1991, the Company has incurred significant losses from operations and, as of September 30, 2022, had incurred an accumulated deficit of $624.9 million.

The Company believes that it has sufficient resources to fund its operations at least one year beyond the date that the interim consolidated financial statements are issued. As of September 30, 2022, the Company had a balance of cash and cash equivalents and restricted cash of $29.2 million, of which $22.2 million was held in the financial institutions in the PRC. The Company intends to continue to exercise tight controls over operating expenditures and will continue to pursue opportunities, as required, to raise additional capital and will also actively pursue non- or less-dilutive capital raising arrangements or opportunities.

Risks and Uncertainties

Since the second quarter of 2022, due to the outbreak of Omicron and other variants of COVID-19, the lockdown in Shanghai and restrictions in other major cities in China led to limitation of access to local hospitals, which had an adverse impact on the sales of EVOMELA® for the second and the third quarters. The restrictions also adversely impacted the enrollment of patients for the CNCT19 Phase II registration studies. Recently, the pandemic gradually spread nationwide in China, and many small and medium-sized cities have been upgrading their control measures ever since the third quarter. These series of control measures are expected to adversely impact our sales activities for the remainder of 2022. Given that such COVID-19 related restrictions are beyond our control, at this stage, it is unable to assess for how long such COVID-19 related restrictions may continue in China, and the full extent to which such restrictions may directly and indirectly impact our business operations. Considering the uncertainty of the development of COVID-19 pandemic, we will continue to pay close attention on the development of the COVID-19 pandemic and dedicate resources to take any necessary measures in a timely manner to minimize the unfavorable impact on our businesses and operations.